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NCT05604898
A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Conditions: Psoriasis
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE2
Enrollment: 139
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Location: China
Summary
The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
Eligibility Criteria
Inclusion Criteria:Must be 18 Years to 65 Years, both male and female.BMI ≥18 kg/m^2 and ≤32 kg/m^2 ,and male weight ≥50 kg, female weight ≥45 kg during the screening.Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator..Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=3.According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).Subject must be able to understand and comply with the requirements of the study.
and must participate voluntarily and sign the written informed consent.Exclusion Criteria:History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline.History of drug-induced psoriasis.Ongoing use of prohibited treatments.Have previously received any drug that directly targets IL-17.Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to randomization.Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), syphilis and/ or active tuberculosis.Pregnant or lactating women.
Source: ClinicalTrials.gov (NCT05604898). StuddyBuddy aggregates publicly available trial information.